Is michelia leaf oil FDA-compliant for the US market?
Yes — for flavour use, michelia leaf oil is supported by FEMA GRAS number 3950 and falls under the FDA GRAS framework of 21 CFR §182.20 (essential oils, oleoresins and natural extractives), which means it can be used as a natural flavouring substance following good manufacturing practice.
US Compliance Position
| Item | Detail |
|---|---|
| FEMA GRAS No. | 3950 (Michelia alba oil — covers leaf, flower, net oil and concrete) |
| FDA GRAS framework | 21 CFR §182.20 — natural flavour materials |
| CAS No. | 92457-18-6 (EINECS 296-299-2) |
| GRAS reassessment | 2020 — Fukushima et al., Food Chem. Toxicol. 145 (re-evaluation passed) |
| Use level | As needed (good manufacturing practice), flavour-grade only |
Practical Notes for US Buyers
- The FEMA 3950 designation is the document your US flavour-house customer will ask for — we print it on the COA
- For cosmetic use in the US, michelia leaf oil is a common botanical fragrance ingredient under FDA cosmetic jurisdiction (not pre-approved, but no prohibited constituents at compliant usage)
- Methyl eugenol is naturally present (~0.25%) — while permitted in flavour at GMP levels, US brands reformulating topically should check IFRA guidance and their own safety requirements
- We can provide the FEMA library reference, GC-MS data and SDS so your US documentation package is complete
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This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.
